Moderna’s Covid Vaccine Is Next Up for FDA Consideration

A nurse prepares a shot that is part of a Covid-19 vaccine candidate developed by the National Institutes of Health and Moderna Inc. in Binghamton, N.Y. (AP Photo/Hans Pennink, File)

WASHINGTON (CN) — Moderna is ready to seek emergency use authorization for the vaccine it has reported as over 94% effective in preventing Covid-19, the Massachusetts-based drugmaker said Monday.

The announcement is the second of its kind in as many weeks as the virus continues to spread rapidly throughout the U.S. More than 13 million Americans have been infected with the novel coronavirus as of Monday, and more than 260,000 have died, according to the Johns Hopkins Coronavirus Resource Center.

Moderna’s push to get its drug greenlit by the Food and Drug Administration follows the emergency clearance sought by Pfizer on Nov. 20. The New York City-based Pfizer was first to reach this milestone in the global vaccine race.

Hailing its efficacy after three clinical trials, Moderna CEO Stéphane Bancel said in a statement Monday he believes the “positive primary analysis” conducted at this stage bodes extremely well for a world eagerly awaiting a vaccine. 

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Bancel said.

Encouragingly, Moderna reports that just 196 individuals in its pool of 30,000 trial participants developed Covid-19, and that most of those cases cropped up in subjects who had received a placebo. There was only one Covid-19-related death in Moderna’s study thus far. The company confirmed in its announcement Monday the death occurred in the placebo group.

A scientific review of the company’s findings is still in the queue, and more information will become public as the FDA gets its evaluation process underway. The regulatory agency will consider Pfizer’s emergency use authorization at a December 10 public hearing, and Moderna’s follows on December 17.

In terms of safety, Moderna says it has tested its vaccine’s efficacy across categories of age, race, ethnicity and gender. For example, of the 196 Covid-19 positive cases in its study, 33 were older adults over 65, Moderna reported. Forty-two subjects identified as a race other than white. 

Racial equity in vaccine development and distribution is a key factor given the disproportionate impact the virus has had on Black, Latin, Asian and indigenous people, many of whom are front line or essential workers during the pandemic.

Last week the Advisory Committee on Immunization Practices, a group of public health and medical professionals that provides guidance to organizations like the Centers for Disease Control and Prevention and others, highlighted in a report the pressing need to “promote justice” and act ethically in order to expedite the nation’s escape from the pandemic.

It recommends first offering vaccines to health care workers, who are often of color or fall into lower socioeconomic brackets. The report also recommends kicking off the secondary phase of vaccines for other essential workers like teachers. People with high risk underlying medical conditions or those over 65 would also be included in this wave of distribution, potentially.

While Moderna files for emergency clearance in America, it also announced on Monday its pursuit of a “conditional marketing authorization” through the European Medicines Agency. A rolling review is underway there now in conjunction with regulatory health agencies from the United Kingdom, Canada, Singapore, Israel and others.

With public FDA meetings for Pfizer and Moderna scheduled in rapid succession over the next two weeks that means cold storage and distribution planning now is key.

“The company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted,” Moderna said in a statement Monday. 

Pfizer’s vaccine must be stored in special freezers so that it can remain at a very cold -94 degrees Fahrenheit to remain viable. Moderna’s vaccine appears less volatile for now. It remains stable when held in cold storage between 36 and 46 degrees Fahrenheit. It also can last up to six months in a deep freeze of -4 degrees Fahrenheit.

Health and Human Services Secretary Alex Azar has said in recent weeks that he believes 40 million doses of a Covid-19 vaccine will be ready by the year’s end. But each vaccine requires two doses, meaning the total inoculated at first blush would be 20 million.

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